A Comparison of Symbicort® pMDI 2 x 160/4.5 μg Bid and 2 x 80/4.5 μg Bid With Formoterol Turbuhaler® 2 x 4.5 μg Bid and Placebo in Patients With COPD

Trial ID or NCT#

NCT00206167

Status

not recruiting iconNOT RECRUITING

Purpose

The purpose of this study is to compare Symbicort in a pressurized metered-dose inhaler (pMDI) with formoterol and placebo in the long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

Official Title

A 12-Month Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter Efficacy and Safety Study of Symbicort® pMDI 2 x 160/4.5 μg Bid and 2 x 80/4.5 μg Bid Compared to Formoterol Turbuhaler® 2 x 4.5 μg Bid and Placebo in Patients With COPD

Eligibility Criteria

Ages Eligible for Study: Older than 40 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * A clinical diagnosis of COPD with symptoms for more than 2 years.* Smoking history of 10 or more pack years* A history of at least one COPD exacerbation requiring a course of oral steroids and/or antibiotics within 1-12 months before first visit.
Exclusion Criteria:
  1. * A history of asthma* Patients taking oral steroids* Any significant disease or disorder that may jeopardize the safety of the patient
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Investigator(s)

Ware Kuschner, M.D.

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Contact

Ware Kuschner
6504935000 x 63544

View on ClinicalTrials.gov